Antiretroviral Generics in Africa: How Local Production Is Transforming HIV Treatment Access

For decades, Africa relied on pills shipped from India and Europe to treat HIV. But in May 2025, something changed. For the first time ever, the Global Fund an international financing organization that supports programs to fight AIDS, tuberculosis, and malaria bought an HIV medicine made entirely in Africa. The drug, called TLD a fixed-dose combination of tenofovir, lamivudine, and dolutegravir, now the global standard for first-line HIV treatment, was produced by Universal Corporation Ltd a Kenyan pharmaceutical company that became the first African manufacturer to receive WHO prequalification for TLD in 2023 and delivered to Mozambique. This isn’t just a symbolic win-it’s the start of a real shift in how Africa gets its life-saving drugs.

Why Local Production Matters More Than Ever

Africa carries 65% of the world’s HIV cases, but for years, it imported nearly 80% of its medicines. That meant long delays when global supply chains broke down-like during the pandemic. A shipment stuck in a port, a factory shutdown in India, or a price hike from a foreign supplier could leave clinics without pills. People stopped treatment. Viral loads spiked. Resistance grew. The system was fragile because it was built on dependence, not resilience.

Now, local manufacturing changes the game. When a country makes its own medicines, it controls the timeline. It can respond faster to outbreaks. It can adjust production if new strains emerge. And crucially, it keeps money circulating within the continent instead of sending it overseas.

The TLD regimen is the backbone of modern HIV treatment. It’s simpler, safer, and more effective than older combinations. It has a high barrier to drug resistance, meaning fewer people develop treatment failure. And because it’s now being made in Africa, the cost per patient per year is dropping further-below $50 in some cases. That’s less than half the price of imported versions just five years ago.

The WHO Prequalification Difference

Not every pill made in Africa can be used by global health programs. To be eligible for procurement by the Global Fund or WHO the World Health Organization, which sets international health standards, a drug must pass something called WHO prequalification. It’s not just a stamp of approval-it’s a full audit of the factory, the testing labs, the quality control, and even the storage systems.

Universal Corporation spent over two years preparing. They upgraded their equipment, trained staff, and submitted thousands of documents. When they passed in 2023, it sent a signal: African manufacturers can meet global standards. That opened the door for the Global Fund to buy TLD from them in 2025. This wasn’t charity. It was a market signal. Buyers were saying: “We’ll pay for quality made here.”

Before this, only Indian manufacturers had the scale and track record to supply African countries at low cost. Now, African companies are proving they can too. And that’s changing the entire supply chain.

From Pills to Injections: The Next Wave

HIV treatment is no longer just about daily pills. In October 2025, South Africa became the first African country to register a long-acting injectable treatment: cabotegravir long-acting (CAB LA) a twice-yearly injection that replaces daily pills for people living with HIV. This is huge. For many, taking a pill every day is hard-due to stigma, work schedules, or lack of privacy. An injection every six months? That’s a game-changer.

Gilead Sciences, the original maker of CAB LA, has already licensed six African manufacturers to produce generic versions. Experts predict prices could drop by 80-90% once generics hit the market. That means this advanced treatment could be available across Africa within two years-not just in wealthy cities, but in rural clinics too.

And it’s not stopping there. Lenacapavir a next-generation antiretroviral used for both treatment and prevention (PrEP) is also entering the scene. Gilead has agreed to supply it at no profit to low-income countries until generics are ready. By the end of 2025, they plan to submit regulatory applications in 18 African countries that together account for 70% of the continent’s HIV burden. This isn’t just about treatment-it’s about prevention, too.

Building the Whole System, Not Just the Pills

Manufacturing pills is only one piece. You also need diagnostics, supply chains, trained health workers, and strong health systems. That’s why companies like Codix Bio a Nigerian diagnostics firm that now manufactures HIV rapid tests under WHO technology transfer are just as important.

Before, many clinics had to send blood samples to distant labs for HIV testing. Results took weeks. People never came back. Now, with locally made rapid tests, a nurse can give a result in 20 minutes. That’s how you find people who don’t know they’re infected. That’s how you get them on treatment fast.

WHO’s Health Technology Access Programme, along with the Medicines Patent Pool an organization that negotiates voluntary licensing agreements to expand access to medicines, has been key in transferring this technology. It’s not about giving away patents-it’s about sharing knowledge so African companies can build their own capacity.

Progress, But Not Enough

By 2025, Africa needed about 15 million person-years of first-line ARV treatment annually. But African manufacturers were only producing enough for 1.2 million people. That’s less than 8% of the need. The gap is still huge.

That’s why the African Union’s Pharmaceutical Manufacturing Plan for Africa (PMPA) a continent-wide strategy to increase local pharmaceutical production from 2-3% to 40% by 2040 exists. It’s ambitious. But it’s necessary. Right now, only a handful of countries-Kenya, South Africa, Nigeria, Rwanda, and Ethiopia-are leading the way. Others lag due to weak regulation, lack of investment, or unstable policies.

And it’s not just about making pills. It’s about African leadership. For too long, HIV research and treatment protocols were designed in labs in the U.S. or Europe. Now, African scientists are pushing for “Africanizing research”-so treatments are tested on African populations, with African strains, and tailored to African lifestyles. That’s how you get real results.

What’s Next? The Road to 2030

By 2030, experts predict African-made ARVs could supply 20-30% of the continent’s needs. That’s still not enough to replace imports entirely-but it’s enough to break the cycle of dependency. It’s enough to make supply chains more resilient. It’s enough to save lives when the next crisis hits.

Three things will decide if this happens:

1. Continued funding-from the Global Fund, Unitaid, Gates Foundation, and African governments themselves.
2. Regulatory harmonization-countries need to agree on one set of quality standards so one approved drug can be sold everywhere.
3. Market predictability-manufacturers need to know they’ll get orders year after year. That’s why the Global Fund’s procurement model is so smart: it creates guaranteed demand.

South Africa’s record-fast approval of CAB LA shows what’s possible when regulators work fast. Nigeria’s Codix Bio shows how diagnostics can leap ahead. Kenya’s Universal Corporation proves manufacturing can scale. This isn’t a dream-it’s happening, one pill, one test, one injection at a time.

Real Impact, One Country at a Time

In Mozambique, the first shipment of African-made TLD reached 120 clinics. Over 72,000 people started treatment within six months. That’s 72,000 people who didn’t have to wait. 72,000 people who didn’t have to risk a shipment being delayed. 72,000 lives that now have more stability.

Dr. Ussene Hilário Isse, Mozambique’s Minister of Health, put it plainly: “Africa’s growing capacity to locally produce lifesaving medications marks a strategic shift.” It’s not just about HIV. It’s about health sovereignty. It’s about dignity. It’s about saying: “We can do this ourselves.”